NCT06246565尚未招募2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-designed Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of HS-10383 in Chinese Adult Subjects With Refractory or Unexplained Chronic Cough (RUCC)
Jiangsu Hansoh Pharmaceutical Co., Ltd.0 个研究点目标入组 276 人开始时间: 2024年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 276
- 主要终点
- 24-Hour Cough Frequency
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-designed phase 2 clinical trial to evaluate the efficacy, safety and pharmacokinetic (PK) characteristics of HS-10383 in Chinese adult subjects with refractory or unexplained chronic cough (RUCC).
详细描述
The primary objectives of this study are to evaluate the efficacy of HS-10383 in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of HS-10383. The primary hypothesis is that at least one dose of HS-10383 is superior to placebo in reducing coughs per hour (over 24 hours) at Week 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects should have a full understanding of the study contents, process, and possible adverse reactions, and voluntarily sign the informed consent form;
- •Subjects aged 18-70 years (including the critical value) with RUCC ≥1 year (diagnosis of RUCC according to the Expert Consensus on Diagnosis and Treatment of Refractory Chronic Cough in China [Released in 2021]);
- •Subjects whose serum pregnancy test is negative in both screening and baseline visits;
排除标准
- •Subjects who are diagnosed with chronic obstructive pulmonary disease, bronchiectasis, idiopathic pulmonary fibrosis and other serious lung diseases;
- •Any physiological or mental disease or condition that may increase study risks or interfere with the conduct of the study or affect the ability to complete this study in the opinion of the investigator, such as medical history of depression;
- •Subjects who cannot meet the requirements for piror treatment or who cannot adhere to the concomitant treatment as specified in Section 6.7-Prior/concomitant medications and non-drug treatment.
- •Subjects with positive hepatitis A IgM antibody, hepatitis C antibody (HCVAb), syphilis antibody or human immunodeficiency virus (HIV) antibody at screening visit; subjects with positive hepatitis B surface antigen (HBsAg) at screening (except for quantitative detection result of HBV-DNA is below the lower limit of the detection reference range).
- •Any former smoker with more than 20 packs/year; or have quited smoking for less than 6 months; or subjects who are still smoking (including e-cigarettes);
- •Subjects who have a history of serious drug, food or environmental allergies, or who are known to be allergic to the ingredients of investigational product;
- •History of drug dependence,drug or alcohol abuse in the past year;
- •Female subjects who are pregnant or breastfeeding;
- •Subjects who have previously received anything that may affect drug absorption, including but not limited to: gastrectomy, gastroplasty, any type of weight-loss surgery, vagotomy or enterotomy;
- •Subjects who have been vaccinated within 30 days before screening visit, or have a vaccination plan during the whole study period.
研究组 & 干预措施
HS-10383 50mg
Experimental
HS-10383 oral dose 50 mg once a day.
干预措施: HS-10383 (Drug)
HS-10383 100mg
Experimental
HS-10383 oral dose 100 mg once a day.
干预措施: HS-10383 (Drug)
HS-10383 200ng
Experimental
HS-10383 oral dose 200 mg once a day.
干预措施: HS-10383 (Drug)
Placebo
Placebo Comparator
Matching Placebo for HS-10383 oral dose once a day
干预措施: HS-10383 Placebo (Drug)
结局指标
主要结局
24-Hour Cough Frequency
时间窗: at Week 4
Assessed using an ambulatory cough monitor
次要结局
- Awake Cough Frequency(at Week 4)
- Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 2 and Week 4.(at Week 2 and Week 4)
- Change from Baseline in Cough Severity Visual Analogue Scale at Week 2 and Week 4;(at Week 2 and Week 4)
研究者
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